Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age30-75
SponsorComphya Inc.
About this trial
The goal of this clinical trial is to assess if a new device is safe to use as a potential treatment for erectile dysfunction following radical prostatectomy.
The main questions it aims to answer are:
* Is the device safe? * Does the device works well? Are the participants satisfied with the device?
Participants will be implanted with the device during the ongoing prostatectomy surgery and will be asked to complete the following tasks during 6 months follow-up:
* Come to the hospital for follow-up visits, * Complete questionnaires, * Activate the device every day, * Measure erection hardness.
Researchers will compare an implanted group (participants having the device) with a control group (participants not having the device) to see if the device works well.
Eligibility criteria
Qualifiers
Men of ages between 30-75 years with indication for nerve-sparing prostatectomy surgery;
Cancer stage T1c and T2a;
Grade Groups 1 and 2 as well as low volume Grade Group 3 (Gleason score 4 + 3 = 7), as determined by biopsy (2 cores or less GG3) or single index MRI lesion of GG3 disease;
IIEF-15 erectile function domain score equal to or greater than 26;
Disqualifiers
Men with neurological disease, including a history of spinal cord injury or trauma;
IIEF-15 erectile function domain score less than 26;
Failure to demonstrate adequate nocturne erectile function prioi prostatectomy (nocturnal RigiScan measure);
Men with PSA > 20 ng/mL;
Trial design
Treatments tested in this trial
- Activation of pro-erectile nerves within the pelvic plexus
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov